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Trial registered on ANZCTR
Registration number
ACTRN12624000886583
Ethics application status
Approved
Date submitted
2/07/2024
Date registered
19/07/2024
Date last updated
19/07/2024
Date data sharing statement initially provided
19/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Hospital in the home for hip fracture patients : a feasibility study
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Scientific title
Hospital in the home for hip fracture patients (HITH4HIPs): a feasibility study
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Secondary ID [1]
312429
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip fracture
334245
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Condition category
Condition code
Injuries and Accidents
330908
330908
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0
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Fractures
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Musculoskeletal
330909
330909
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0
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Osteoporosis
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Public Health
330910
330910
0
0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Setting: The Orthopaedic Department is rolling out a new pathway within its hip fracture care pathway. It is adding a hospital in the home (HITH) component for patients who fit the criteria for eligibility. As per the NSW Health HITH Guidelines, patients involved in HITH programs must consent to the intervention. The Intervention is NOT a research intervention; it is a clinical intervention; if patients who are eligible decline the intervention, they receive usual care. The research component involves following hip fracture patients regardless of whether they accept or decline the program. Patients do not enroll in the study per se; monitoring of patients to at least 6-weeks post-admission is routine at our facility, including the review of such data by researchers. The program will be reviewed over a 5-6-month period, resources permitting. The final patients to be reviewed in the program will be admitted before 24th December 2024, thus their 6-week follow-up will be in January 2025.
HITH-accepted Group: A hospital in the home (HITH) program is being added to the usual hip fracture care pathway as an alternative model of care for appropriate patients..
This group includes people who meet the eligibility criteria for a HITH program and who consent to participate in the HITH program after discussion with the treating team. Patients and carers are given information about the program, to help them decide whether a HITH program is suitable for them.
Once the person meets the criteria for transfer to the HITH program (this is expected to occur at a minimum 3-4 days after surgery), the person/participant will be transferred to their home. As per the clinical pathway for HITH, HITH staff (comprising a multidisciplinary team, MDT) will review the patient each day (in person and/or over the telephone as appropriate) and provide care that is comparable to that which would have been provided had the person stayed in a physical hospital ward bed. The MDT comprises a full-time physiotherapist, and part-time nurse and occupational therapist. Medical input is provided by the treating team, but reviews by medical staff occur either virtually or via a hospital-based clinic if required. After-hours, patients/carers are requested to contact the hospital, their local doctor or an ambulance depending on the urgency of the problem. The participant will be discharged from the program according to the same criteria used to discharge a patient from usual care (physical hospital ward).
Researchers will review the medical record to extract length of stay in the HITH program, number of HITH visits by staff, complications and any additional healthcare resource use. .
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Intervention code [1]
328935
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Rehabilitation
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Comparator / control treatment
Usual care (HITH-declined gp): This group includes individuals people who are eligible for the HITH program as above, but who decline participation.
Usual care comprises the typical multi-disciplinary care that is provided by both acute-care wards and subacute/rehabilitation wards as required. Patients participating in this pathway will be discharged home once they meet the criteria for discharge, which include the ability to mobilise safely and function at home with available assistance and; the absence of active medical issues requiring ongoing in-hospital specialist input..
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Control group
Active
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Outcomes
Primary outcome [1]
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HITH Program eligibility rate
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Assessment method [1]
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Proportion of people who present over the study period who are eligible for the HITH program (eligible for program/number of low-trauma (osteoporotic) hip fractures presenting). This obtained from the medical records
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Timepoint [1]
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End of the observational period (after 5 months) - December 2024
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Primary outcome [2]
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HITH Program consent rate
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Assessment method [2]
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Proportion of people who are eligible for the program who then consent to the program (eligible plus consent/eligible). This is obtained from the medical record.
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Timepoint [2]
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End of the observational period (5 months) - December 2024
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Primary outcome [3]
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Successful HITH transfer rate
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Assessment method [3]
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Proportion of people who transfer to HITH and who do not transfer back to a physical hospital bed (successful HITH transfer/ total HITH transfers). This is obtained from the medical record.
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Timepoint [3]
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End of the observational period (5 months) - December 2024
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Secondary outcome [1]
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Program acceptability
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Assessment method [1]
436957
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Q12 - Australian Hospital Patient Experience Question Set - "Overall, the quality of the treatment and care I received was: Very good; good; average; poor; very poor"
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Timepoint [1]
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Within 1-3 days following program discharge
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Secondary outcome [2]
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Acute length of stay
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Assessment method [2]
436958
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Count of days the participant/patient occupied a physical acute-care bed. This will be obtained via medical record review
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Timepoint [2]
436958
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End of acute-care bed stay.
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Secondary outcome [3]
436959
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Total length of stay
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Assessment method [3]
436959
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Count of days a participant/patient stayed in an acute-care bed plus any days in a HITH bed (HITH program) or any days in a subacute/rehabilitation facility (usual care). This will be obtained via medical record review
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Timepoint [3]
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End of total episode of care (at discharge from HITH (HITH group) or physical hospital (usual care))
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Secondary outcome [4]
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Discharge destination
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Assessment method [4]
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Proportion of people in each group who were discharged from acute-care to a subacute/rehabilitation facility, and discharged from acute-care to home (either via HITH or without HITH). This will be obtained via medical record review
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Timepoint [4]
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End of episode of care
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Secondary outcome [5]
436961
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Service costs of the program or usual care
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Assessment method [5]
436961
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Cost (dollar amount) of providing either the HITH program or usual care will be obtained from the hospital finance department. Costs will include staffing, investigations, medications, other treatment costs over the episode of care, and transport costs paid by the service (for HITH transfers/returns), readmission costs (for readmission to acute hospital from subacute care)
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Timepoint [5]
436961
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End of the episode of care (i.e after HITH discharge or discharge from the physical hospital)
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Secondary outcome [6]
436962
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Hospital acquired complication
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Assessment method [6]
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The type and count of complications a participant/patient experiences during their total length of stay using the Hospital Acquired Complication (HAC) definition (https://www.safetyandquality.gov.au/our-work/indicators/hospital-acquired-complications#hospital-acquired-complications-list). Additional complications not included in the HAC list but are relevant to hip fracture and thus will also be captured include death, stroke, neuropraxia. A code for "other' (specify) is also an option. This will be obtained via medical record review.
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Timepoint [6]
436962
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- End of total episode of care (with a breakdown for where and when (HITH period vs subacute)
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Secondary outcome [7]
436965
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Hip pain score at rest
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Assessment method [7]
436965
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Hip pain measured on a verbal analogue scale 0-10 (0 = nil; 10 = maximum/severe). This will be obtained via medical record review
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Timepoint [7]
436965
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Daily until discharge from hospital (discharge from HITH or usual care)
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Secondary outcome [8]
436966
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Fear of falling
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Assessment method [8]
436966
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Measured using the Falls Efficacy Scale. Obtained via telephone call after hospital discharge
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Timepoint [8]
436966
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Within 1-3 days after discharge from the program (HITH or usual care)
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Secondary outcome [9]
436967
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Hip pain score on movement
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Assessment method [9]
436967
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Hip pain on movement measured on a verbal analogue scale 0-10 (0 = nil; 10 = maximum/severe). Obtained from the medical record
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Timepoint [9]
436967
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Daily until the end of program (either HITH program or usual care)
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Secondary outcome [10]
436968
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Opioid use
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Assessment method [10]
436968
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Measured using the oMEDD (oral morphine equivalent daily dose as mg/day). Obtained from the medical record
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Timepoint [10]
436968
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Daily over the entire episode of care (period of hospitalisation including HITH period). There will be capacity to break this down further into when (HITH vs subacute)
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Secondary outcome [11]
436969
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Health-related quality of life "today' score. Obtained via telephone call.
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Assessment method [11]
436969
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EQ-5D-5L - VAS (0-100) scale component
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Timepoint [11]
436969
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Within 1-3 days of discharge from hospital (either after HITH discharge or discharge from physical hospital)
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Secondary outcome [12]
436970
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Health related quality of life domains
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Assessment method [12]
436970
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EQ-5D-5L - subdomains. Obtained via telephone call.
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Timepoint [12]
436970
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Within 1-3 days of discharge from the program (either HITH or usual care)
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Secondary outcome [13]
436971
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Adequacy of pain relief
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Assessment method [13]
436971
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Q8 AHPEQS - I received pain relief that met my needs; always; mostly; sometimes, rarely; never; didn't apply. Obtained via telephone call.
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Timepoint [13]
436971
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Within 1-3 days of discharge from the program (HITH or usual care)
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Secondary outcome [14]
436972
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Carer burden
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Assessment method [14]
436972
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Zarit Caregiver Burden survey. Obtained via telephone call. This question is optional for the carer.
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Timepoint [14]
436972
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Within 1-3 days of discharge from the program (HITH or usual care)
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Secondary outcome [15]
436973
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Use of community care services
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Assessment method [15]
436973
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Count of use (per person) of TACP, Compacks or other community services either during the HITH program or after discharge (from HITH or Usual care). This information is obtained from review of the medical record and at the time of the 6-week follow-up (telephone or face-to-face).
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Timepoint [15]
436973
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6-weeks after initial admission to hospital
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Secondary outcome [16]
436974
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Health-related quality of life
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Assessment method [16]
436974
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EQ-5D-5L, obtained either via telephone or face-to-face
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Timepoint [16]
436974
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6-weeks after initial admission
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Secondary outcome [17]
436975
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Mobility
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Assessment method [17]
436975
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Timed up-and-go. Obtained in person at the follow-up clinic.
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Timepoint [17]
436975
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6-12 weeks after initial admission. Note this time point is protracted for this measure because despite being booked for review at 6-weeks post-admission, actual presentation in person to the clinic varies.
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Eligibility
Key inclusion criteria
- Community-dwelling adults aged => 50 years presenting to Liverpool Hospital with a low-trauma (osteoporotic) hip fracture who undergo surgical management.
- Frailty score of 6 or less (moderate frailty) based on the Clinical Frailty Score 1-9
- Anticipated to return to community (private) residence.
- Permitted to weight-bear as tolerated
- Carer available and is willing to help the patient with the HITH program
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Presence of other fractures that would delay discharge.
- Residential location outside the Liverpool and Fairfield Local Government Area.
- Private health insurance.
- Active end-of-life management or palliative care.
- Presence of other impairments which preclude early return home (e.g. significant hemiparesis, complex or disruptive renal dialysis needs, history of daily falls pre-admission, catastrophic complication perioperatively)
- Fracture occurred whilst in hospital for another reason
- Planned return or transfer to a residential aged care facility
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
The researchers do not assign treatment pathway at all. Patients receive the HITH pathway of clinically indicated and they and their carer agree to the pathway.
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
This is a feasibility study and will not be powered to detect statistically significant between-group differences. We expect approximately 15-25 people will consent to the HITH Program over the prospective study period. A similar number or more is expected to be in the HITH declined group. The HITH group outcomes will be compared to patients eligible for HITH but who refused. Descriptive statistics (e.g. mean, standard deviation, medians, range, proportions) will be used to describe the cohort and the contextual variables. For the primary (feasibility) outcomes, the following criteria (i-iii) will need to be met to conclude that the program and or a definitive trial is feasible:
I. A minimum 40% screened are eligible for HITH
II. A minimum 30% eligible consent to HITH
III. Most (>50%) of those eligible have a successful HITH Transfer
Group differences (plus 95% CI) will be reported for secondary outcomes.
It is anticipated that the difference in total LOS and/or EuroQol VAS Today score (within 1-3 days of discharge) between the HITH Consented group and HITH Refused group will be used for determining the sample size required for a definitive trial if such a program is deemed feasible for the population.
Note - Daily pain scores are inconsistently recorded in the medical records for people in hospital under usual care conditions. Usual care daily pain scores will only be reported if at least 75% of this group has a pain score recorded daily. Higher compliance with recording pain scores is expected in the HITH group due to the use of specifically trained staff.
A qualitative study of stakeholders will be conducted alongside this observational study.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
22/07/2024
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Actual
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Date of last participant enrolment
Anticipated
24/12/2024
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Actual
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Date of last data collection
Anticipated
15/03/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
26742
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Liverpool Hospital - Liverpool
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Recruitment postcode(s) [1]
42790
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2170 - Liverpool
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Funding & Sponsors
Funding source category [1]
316841
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Hospital
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Name [1]
316841
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Liverpool Hospital
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Address [1]
316841
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Country [1]
316841
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Australia
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Funding source category [2]
316843
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Other Collaborative groups
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Name [2]
316843
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SPHERE - Sydney Partnership for Health Education Research and Enterprise
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Address [2]
316843
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Country [2]
316843
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Australia
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Funding source category [3]
316844
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Charities/Societies/Foundations
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Name [3]
316844
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Liverpool Catholic Club
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Address [3]
316844
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Country [3]
316844
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Australia
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Primary sponsor type
Hospital
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Name
Liverpool Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319078
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None
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Name [1]
319078
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Address [1]
319078
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Country [1]
319078
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315609
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South Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
315609
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https://www.swslhd.health.nsw.gov.au/ethics/
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Ethics committee country [1]
315609
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Australia
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Date submitted for ethics approval [1]
315609
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02/02/2024
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Approval date [1]
315609
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11/03/2024
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Ethics approval number [1]
315609
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Summary
Brief summary
The study was approved via the Low or Negligible Risk review pathway. It is recommended practice when introducing a new model of care or a new element into a model of care, that it be evaluated properly. In this study, we will observe the effect of the new addition to the clinical pathway - a hospital in the home or HITH program. HITH programs have been included as part of management pathways after low-trauma (osteoporotic) hip fracture since the late 1970s in the United Kingdom. HITH programs are a priority for NSW Health, but their uptake appears to be limited by available resources and published documentation of their effect. In trialling a HITH program here, we aim to establish whether such a program is feasible/practical in our patients. We are not testing a hypothesis, but we will specifically monitor program uptake/acceptance by patients/carers and safety. If the program is feasible, it is hoped its continuation (plus or minus any refinements) are supported by the organization.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Justine Naylor
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Address
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Orthopaedic Dept. Liverpool Hospital, Locked bag 7103
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Country
135238
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Australia
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Phone
135238
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+61 02 8738 9257
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Fax
135238
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Email
135238
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[email protected]
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Contact person for public queries
Name
135239
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Justine Naylor
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Address
135239
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Orthopaedic Dept. Liverpool Hospital, Locked bag 7103
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Country
135239
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Australia
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Phone
135239
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+61 02 8738 9257
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Fax
135239
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Email
135239
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[email protected]
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Contact person for scientific queries
Name
135240
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Justine Naylor
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Address
135240
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Orthopaedic Dept. Liverpool Hospital, Locked bag 7103
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Country
135240
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Australia
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Phone
135240
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+61 02 8738 9257
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Fax
135240
0
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Email
135240
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Patient data (anthropometric, sociodemographic, comorbidity, or outcome data (LOS, complications)) that is stored in the Redcap database can be shared. It is anonymized. The dictionary will accompany any database.
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When will data be available (start and end dates)?
Dec 2025 - Dec 2030
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Available to whom?
Researchers upon reasonable request
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Available for what types of analyses?
Reviews (eg patient-level meta-analysis). Though the study design (observational) may render the data ineligible for most reviews.
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How or where can data be obtained?
From the primary investigator or their representative via the Orthopaedic Department, Liverpool Hospital
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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